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Clindamycin Phosphate
Overview
What is Clindamax?
Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L--α--octopyranoside 2-(dihydrogen phosphate). It has a molecular weight of 504.96, and the molecular formula is CHClNO PS. The structural formula is represented below:
ClindaMax Vaginal Cream (clindamycin phosphate vaginal cream USP, 2%), is a semi-solid, white cream, which contains 2% clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin per gram. The pH of the cream is between 3.0 and 6.0. The cream also contains benzyl alcohol, cetostearyl alcohol, cetyl palmitate, mineral oil, polysorbate 60, propylene glycol, sorbitan monostearate, and stearic acid.
Each applicatorful of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate.
What does Clindamax look like?
What are the available doses of Clindamax?
Sorry No records found.
What should I talk to my health care provider before I take Clindamax?
Sorry No records found
How should I use Clindamax?
ClindaMax Vaginal Cream, is indicated in the treatment of bacterial vaginosis (formerly referred to as vaginitis, vaginitis, nonspecific vaginitis, vaginitis, or anaerobic vaginosis). ClindaMax Vaginal Cream, can be used to treat non-pregnant women and pregnant women during the second and third trimester. (See )
NOTE:
Lactobacillus
Gardnerella
Other pathogens commonly associated with vulvovaginitis, e.g., , , and virus should be ruled out.
The recommended dose is one applicatorful of ClindaMax Vaginal Cream, (5 grams containing approximately 100 mg of clindamycin phosphate) intravaginally, preferably at bedtime, for 3 or 7 consecutive days in non-pregnant patients and for 7 consecutive days in pregnant patients. (See .)
What interacts with Clindamax?
ClindaMax Vaginal Cream, is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream. ClindaMax Vaginal Cream, is also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.
What are the warnings of Clindamax?
Consequently, the extended use of this combination product is not recommended.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of orally and parenterally administered clindamycin, as well as with topical (dermal) formulations of clindamycin. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of clindamycin, even when administered by the vaginal route, because approximately 5% of the clindamycin dose is systemically absorbed from the vagina.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by is a primary cause of "antibiotic-associated" colitis.
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.
What are the precautions of Clindamax?
General
ClindaMax Vaginal Cream, contains ingredients that will cause burning and irritation of the eye. In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water.
The use of ClindaMax Vaginal Cream may result in the overgrowth of nonsusceptible organisms in the vagina. In clinical studies involving 600 non-pregnant women who received treatment for 3 days, was detected, either symptomatically or by culture, in 8.8% of patients. In 9% of the patients, vaginitis was recorded. In clinical studies involving 1325 non-pregnant women who received treatment for 7 days, was detected, either symptomatically or by culture, in 10.5% of patients. Vaginitis was recorded in 10.7% of the patients. In 180 pregnant women who received treatment for 7 days, was detected, either symptomatically or by culture, in 13.3% of patients. In 7.2% of the patients, vaginitis was recorded. , as reported here, includes the terms: vaginal moniliasis and moniliasis (body as a whole). Vaginitis includes the terms: vulvo-vaginal disorder, vulvovaginitis, vaginal discharge, trichomonal vaginitis, and vaginitis.
Information for the Patient
The patient should be instructed not to engage in vaginal intercourse, or use other vaginal products (such as tampons or douches) during treatment with this product.
The patient should also be advised that this cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, use of such products within 72 hours following treatment with ClindaMax
Vaginal Cream
clindamycin phosphate vaginal cream 2%), is not recommended.
Drug Interactions
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. Genotoxicity tests performed included a rat micronucleus test and an Ames test. Both tests were negative. Fertility studies in rats treated orally with up to 300 mg/kg/day (31 times the human exposure based on mg/m ) revealed no effects on fertility or mating ability.
Pregnancy: Teratogenic effects
There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. This drug should be used during the first trimester of pregnancy only if clearly needed.
Clindamycin phosphate vaginal cream 2% has been studied in pregnant women during the second trimester. In women treated for seven days, abnormal labor was reported in 1.1% of patients who received clindamycin phosphate vaginal cream 2% compared with 0.5% of patients who received placebo.
Reproduction studies have been performed in rats and mice using oral and parenteral doses of clindamycin up to 600 mg/kg/day (62 and 25 times, respectively, the maximum human exposure based on mg/m ) and have revealed no evidence of harm to the fetus due to clindamycin. In one mouse strain, cleft palates were observed in treated fetuses; this outcome was not produced in other mouse strains or in other species and is, therefore, considered to be a strain specific effect.
See ; ; and .
Nursing Mothers
Clindamycin has been detected in human milk after oral or parenteral administration. It is not known if clindamycin is excreted in human milk following the use of vaginally administered clindamycin phosphate.
Because of the potential for serious adverse reactions in nursing infants from clindamycin phosphate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies for clindamycin vaginal cream 2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
What are the side effects of Clindamax?
What should I look out for while using Clindamax?
ClindaMax Vaginal Cream, is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream. ClindaMax Vaginal Cream, is also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of orally and parenterally administered clindamycin, as well as with topical (dermal) formulations of clindamycin. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of clindamycin, even when administered by the vaginal route, because approximately 5% of the clindamycin dose is systemically absorbed from the vagina.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by is a primary cause of "antibiotic-associated" colitis.
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.
What might happen if I take too much Clindamax?
Vaginally applied ClindaMax Vaginal Cream could be absorbed in sufficient amounts to produce systemic effects. (See .)
How should I store and handle Clindamax?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .ClindaMax Vaginal Cream (clindamycin phosphate vaginal cream USP, 2%) is a white to off-white cream having a slight odor and is supplied as follows:Store at 20° to 25°C (68° to 77° F)[see USP Controlled Room Temperature].ClindaMax Vaginal Cream (clindamycin phosphate vaginal cream USP, 2%) is a white to off-white cream having a slight odor and is supplied as follows:Store at 20° to 25°C (68° to 77° F)[see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered to 6 healthy female volunteers for 7 days, approximately 5% (range 0.6% to 11%) of the administered dose was absorbed systemically. The peak serum clindamycin concentration observed on the first day averaged 18 ng/mL (range 4 to 47 ng/mL) and on day 7 it averaged 25 ng/mL (range 6 to 61 ng/mL). These peak concentrations were attained approximately 10 hours post-dosing (range 4-24 hours).
Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered for 7 consecutive days to 5 women with bacterial vaginosis, absorption was slower and less variable than that observed in healthy females. Approximately 5% (range 2% to 8%) of the dose was absorbed systemically. The peak serum clindamycin concentration observed on the first day averaged 13 ng/mL (range 6 to 34 ng/mL) and on day 7 it averaged 16 ng/mL (range 7 to 26 ng/mL). These peak concentrations were attained approximately 14 hours post-dosing (range 4-24 hours).
There was little or no systemic accumulation of clindamycin after repeated vaginal dosing of clindamycin phosphate vaginal cream 2%. The systemic half-life was 1.5 to 2.6 hours.
Non-Clinical Toxicology
ClindaMax Vaginal Cream, is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream. ClindaMax Vaginal Cream, is also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of orally and parenterally administered clindamycin, as well as with topical (dermal) formulations of clindamycin. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of clindamycin, even when administered by the vaginal route, because approximately 5% of the clindamycin dose is systemically absorbed from the vagina.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by is a primary cause of "antibiotic-associated" colitis.
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
ClindaMax Vaginal Cream, contains ingredients that will cause burning and irritation of the eye. In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water.
The use of ClindaMax Vaginal Cream may result in the overgrowth of nonsusceptible organisms in the vagina. In clinical studies involving 600 non-pregnant women who received treatment for 3 days, was detected, either symptomatically or by culture, in 8.8% of patients. In 9% of the patients, vaginitis was recorded. In clinical studies involving 1325 non-pregnant women who received treatment for 7 days, was detected, either symptomatically or by culture, in 10.5% of patients. Vaginitis was recorded in 10.7% of the patients. In 180 pregnant women who received treatment for 7 days, was detected, either symptomatically or by culture, in 13.3% of patients. In 7.2% of the patients, vaginitis was recorded. , as reported here, includes the terms: vaginal moniliasis and moniliasis (body as a whole). Vaginitis includes the terms: vulvo-vaginal disorder, vulvovaginitis, vaginal discharge, trichomonal vaginitis, and vaginitis.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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